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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K854252
Device Name TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER
Applicant
Transtracheal Systems
1721 E. 19th. Ave.
Suite 404
Denver,  CO  80218
Applicant Contact PETER L DURANTE
Correspondent
Transtracheal Systems
1721 E. 19th. Ave.
Suite 404
Denver,  CO  80218
Correspondent Contact PETER L DURANTE
Regulation Number868.5800
Classification Product Code
BTO  
Date Received10/22/1985
Decision Date 02/03/1986
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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